EyeBio
Associate Principal Scientist, Analytical R&D (Microbiologist) - Onsite
EyeBio, Rahway, New Jersey, us, 07065
Overview
Associate Principal Scientist - Microbiologist. Join us and experience our culture first-hand one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Associate Principal Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a GMP microbiology laboratory including finished products testing, utilities, and environmental monitoring. While working within a fast-paced, integrated, multidisciplinary team environment, the candidate is expected to have a strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the Rahway, New Jersey site. Primary Responsibilities
Lead the execution of microbiology finished product testing, utilities, and environmental monitoring in GMP environment Leverage QC microbiology expertise as a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological indicator challenge tests, and method suitability Drive experimental design, execution, and data interpretation of microbiology data Oversee the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles Execute test method suitability studies and implement microbiology methods to support release and stability testing of small molecule, biologic, and vaccines finished drug products Troubleshoot and lead investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions Partner with internal stakeholders and partners including Quality, Pipeline, and Operations Supervise microbiology testing, data entry, data review, and authorise/approve analytical reports and data summaries Conduct project management and/or scientific oversight of studies performed at Contract Laboratories Contribute expertise and creativity to the collective knowledge and aid in solving complex problems Support internal and external compliance audit activities Education Minimum Requirements
Minimum 3 years of pharmaceutical industry experience for applicants with a PhD degree; 5 years of experience with a MS degree, or 10 years of experience with a BS in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience Required Experience and Skills
A proven record of strong technical problem solving and laboratory experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role. Extensive knowledge and experience of microbiology testing in context of environmental monitoring, aseptic manufacturing, and finished product testing in a GMP environment Expertise in nonsterile and aseptic manufacturing and associated GMP product testing Experience in leading and supporting quality investigations in the microbiology discipline Experience with internal / external audit process and authoring responses to observations Knowledge of current microbiology industry guidelines and compendia Experience with MODA preferred Required Skills
Adaptability Analytical Method Development Assay Development Biological Assay Development Biological Sciences Biomedical Sciences Cell-Based Assays Chromatographic Techniques Cross-Functional Teamwork Environmental Monitoring Environmental Monitoring Systems GMP Compliance Good Manufacturing Practices (GMP) High Resolution Mass Spectrometry (HRMS) Liquid Chromatography-Mass Spectrometry (LC-MS) Mass Spectrometry Analysis Microbiological Test Molecular Microbiology Process Analytical Technology (PAT) Project Management US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid schedule. The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at the compensation and benefits page. You can apply for this role through the company jobs site. The application deadline for this position is stated on this posting.
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Associate Principal Scientist - Microbiologist. Join us and experience our culture first-hand one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Associate Principal Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a GMP microbiology laboratory including finished products testing, utilities, and environmental monitoring. While working within a fast-paced, integrated, multidisciplinary team environment, the candidate is expected to have a strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the Rahway, New Jersey site. Primary Responsibilities
Lead the execution of microbiology finished product testing, utilities, and environmental monitoring in GMP environment Leverage QC microbiology expertise as a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological indicator challenge tests, and method suitability Drive experimental design, execution, and data interpretation of microbiology data Oversee the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles Execute test method suitability studies and implement microbiology methods to support release and stability testing of small molecule, biologic, and vaccines finished drug products Troubleshoot and lead investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions Partner with internal stakeholders and partners including Quality, Pipeline, and Operations Supervise microbiology testing, data entry, data review, and authorise/approve analytical reports and data summaries Conduct project management and/or scientific oversight of studies performed at Contract Laboratories Contribute expertise and creativity to the collective knowledge and aid in solving complex problems Support internal and external compliance audit activities Education Minimum Requirements
Minimum 3 years of pharmaceutical industry experience for applicants with a PhD degree; 5 years of experience with a MS degree, or 10 years of experience with a BS in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience Required Experience and Skills
A proven record of strong technical problem solving and laboratory experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role. Extensive knowledge and experience of microbiology testing in context of environmental monitoring, aseptic manufacturing, and finished product testing in a GMP environment Expertise in nonsterile and aseptic manufacturing and associated GMP product testing Experience in leading and supporting quality investigations in the microbiology discipline Experience with internal / external audit process and authoring responses to observations Knowledge of current microbiology industry guidelines and compendia Experience with MODA preferred Required Skills
Adaptability Analytical Method Development Assay Development Biological Assay Development Biological Sciences Biomedical Sciences Cell-Based Assays Chromatographic Techniques Cross-Functional Teamwork Environmental Monitoring Environmental Monitoring Systems GMP Compliance Good Manufacturing Practices (GMP) High Resolution Mass Spectrometry (HRMS) Liquid Chromatography-Mass Spectrometry (LC-MS) Mass Spectrometry Analysis Microbiological Test Molecular Microbiology Process Analytical Technology (PAT) Project Management US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid schedule. The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at the compensation and benefits page. You can apply for this role through the company jobs site. The application deadline for this position is stated on this posting.
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